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FDA 510(k)

DIAMEDIX IS-RF TEST SYSTEM

K-Number: K974889 · 1998-03-06

ApplicantDiamedix Corp.
Decision Date1998-03-06
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIAMEDIX IS-RF TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 1998-03-06 under 510(k) number K974889. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAMEDIX IS-RF TEST SYSTEM?

DIAMEDIX IS-RF TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-06. The listed applicant is Diamedix Corp.. The 510(k) number is K974889.

When did DIAMEDIX IS-RF TEST SYSTEM receive FDA 510(k) clearance?

DIAMEDIX IS-RF TEST SYSTEM received FDA 510(k) clearance on 1998-03-06, under 510(k) number K974889.

Who is the listed applicant for DIAMEDIX IS-RF TEST SYSTEM?

The FDA 510(k) record lists Diamedix Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAMEDIX IS-RF TEST SYSTEM?

The FDA product code for DIAMEDIX IS-RF TEST SYSTEM is DHR.

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Other records listing Diamedix Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093101MAGO 4SK021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEMK013956DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREENK013628DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEMK012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEMK012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

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Related Devices (Code: DHR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical CompanyK190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc.K182747EliA RF IgM ImmunoassayPhadia ABK162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMPhadia US, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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